Status:
RECRUITING
Study to Evaluate the Performance of Navigated TKA With OrthoPilot® pheno4u TKA Level 1
Lead Sponsor:
Aesculap AG
Collaborating Sponsors:
Raylytic GmbH
Conditions:
Osteoarthritis, Knee
Joint Diseases
Eligibility:
All Genders
18-80 years
Brief Summary
The purpose of this PMCF study is to demonstrate the accuracy of navigation using the new pheno4uTKA Level 1 software for OrthoPilot Elite® and to evaluate its safety and performance. Patient-related...
Eligibility Criteria
Inclusion
- Indication for a TKA with the OrthoPilot® Navigation System with a Aesculap total knee endo-prosthesis
- Written signed informed consent of patient
- Willingness and mental ability to participate at the long-term follow-up examinations
Exclusion
- Pregnancy
- Patients \< 18 years or \> 80 years
- Patients unable to participate at the follow-up examination (physically, mentally)
- Previous joint replacement at the index knee
- ASA classification \> 3 ( ASA I: A healthy patient without systemic diseases. ASA II: A patient with a mild systemic disease that is well controlled (e.g., well-controlled diabetes or hypertension). ASA III: A patient with a severe systemic disease that causes functional limitations (e.g., poorly controlled diabetes, COPD). ASA IV: A patient with a life-threatening systemic disease (e.g., severe heart failure, sepsis). ASA V: A dying patient who is not expected to survive without the operation. ASA VI: A deceased patient whose organs are being removed for donation.)
Key Trial Info
Start Date :
October 7 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06955481
Start Date
October 7 2025
End Date
June 1 2028
Last Update
November 17 2025
Active Locations (4)
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1
Šumperk Hospital Inc.
Šumperk, Czechia, 78701
2
Klinikum Konstanz GmbH
Konstanz, Baden-Wurttemberg, Germany, 78464
3
Park-Klinik Weißensee
Berlin, Germany, 13086
4
Universitätsklinikum Carl Gustav Carus
Dresden, Germany, 01307